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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystoscope And Accessories, Flexible/Rigid
510(k) Number K202957
Device Name Flexible Video Cysto-Urethroscope (C-view)
Applicant
KARL STORZ Endoscopy-America, Inc.
2151 E. Grand Ave.
El Segundo,  CA  90245
Applicant Contact Winkie Wong
Correspondent
KARL STORZ Endoscopy-America, Inc.
2151 E. Grand Ave.
El Segundo,  CA  90245
Correspondent Contact Winkie Wong
Regulation Number876.1500
Classification Product Code
FAJ  
Subsequent Product Code
FBO  
Date Received09/30/2020
Decision Date 10/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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